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Metronidazole API Manufacturer for Poland | WHO GMP Certified India
Metronidazole API Manufacturer for Poland — WHO GMP Certified India
Aarise Pharmaceuticals is a WHO GMP certified Metronidazole API manufacturer in Haridwar, India, supplying USP/BP/IP grade Metronidazole (CAS 443-48-1) to pharmaceutical companies in Poland. We are a direct manufacturer — not a trader — with a NABL-accredited QC laboratory and full URPL/EMA-ready documentation.
About Our Metronidazole API Manufacturing
- Manufacturing Site: SIDCUL Industrial Area, Haridwar, Uttarakhand, India
- Certification: WHO GMP (current), ISO 9001:2015
- QC Lab: NABL-accredited — all testing done in-house
- Grade: USP/BP/IP pharmacopeial grade at 99.0% purity
- Capacity: 100g samples to multi-tonne commercial batches
- Lead Time: 5-7 days standard
Why Choose Aarise as Your Metronidazole API Manufacturer for Poland?
- Direct manufacturer pricing — no broker or agent markup
- WHO GMP certified — accepted by URPL/EMA
- NABL-accredited QC — batch-specific COA from certified analysts
- URPL/EMA-ready documentation — COA, MSDS, COPP, DMF support, COO
- Dedicated export team — experienced in Poland import compliance
- Fast delivery — air freight to Poland in 3-7 days
Manufacturing Compliance for Poland Market
Our Metronidazole API manufacturing complies with URPL (Office for Registration of Medicinal Products) under EMA framework requirements. EU GMP or EMA-recognised WHO GMP, EU qualified person for import, Poland is a major generic drug manufacturing hub in Central Europe. We provide all documentation needed for URPL/EMA import clearance, including DMF filing support.
Quality Control — Metronidazole API
- HPLC purity testing — 99.0% minimum
- Impurity profiling per USP/BP/IP pharmacopeial specification
- Residual solvents — ICH Q3C compliant
- Heavy metals — ICH Q3D compliant
- Stability testing — ICH Q1A compliant
- Microbial testing where applicable
To qualify Aarise Pharmaceuticals as your Metronidazole API manufacturer for Poland, contact us at +91 9899783330. We provide GMP certificates, facility information, audit-ready documentation, and free samples within 24 hours of request.
Frequently Asked Questions
Which is the best Metronidazole API manufacturer for Poland?
Aarise Pharmaceuticals is a WHO GMP certified Metronidazole API manufacturer in Haridwar, India, supplying 99.0% USP/BP/IP grade Metronidazole (CAS 443-48-1) to buyers in Poland with full URPL/EMA-compliant documentation. We are a direct manufacturer with NABL-accredited QC — no intermediaries.
Are Indian Metronidazole API manufacturers URPL/EMA approved?
WHO GMP certified Indian manufacturers like Aarise Pharmaceuticals are recognised by URPL/EMA for API imports. EU GMP or EMA-recognised WHO GMP, EU qualified person for import, Poland is a major generic drug manufacturing hub in Central Europe. We provide all required documentation for smooth URPL/EMA import clearance.
How do I verify a Metronidazole API manufacturer in India?
Verify a Metronidazole API manufacturer by: 1) Checking their WHO GMP certificate (current, from Central Drugs Standard Control Organisation India). 2) Requesting a facility audit or inspection report. 3) Verifying NABL accreditation for QC laboratory. 4) Checking COA against pharmacopeial specifications (USP/BP). Aarise Pharmaceuticals provides all verification documents on request.
What is the manufacturing capacity for Metronidazole API at Aarise?
Aarise Pharmaceuticals has dedicated manufacturing capacity for Metronidazole API at our Haridwar facility. We can supply from 100g sample quantities to multi-tonne commercial batches. Lead time is 5-7 days for standard orders. Contact us for capacity confirmation for large-volume requirements.
Can I visit the Metronidazole API manufacturing facility before ordering?
Yes. Aarise Pharmaceuticals welcomes facility audits and pre-qualification visits at our Haridwar, Uttarakhand facility. We can also provide an audit-ready documentation pack (GMP certificate, facility layout, QC SOP list, batch records) for remote quality assessment. Contact us at +91 9899783330 to schedule a visit.